AFO Prescription to Optimize Post-Stroke Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-fabricated (PF) ankle-foot orthosis (AFO), Carbon-strut (CS) ankle-foot orthosis (AFO), Multifunctional articulating (MA) ankle-foot orthosis (AFO).
- Who it may be relevant to
- Registry conditions: Ankle Foot Orthosis (AFO), Stroke Patients, Post-Stroke Hemiparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life
Overview
The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will: 1. Identify the factors that significantly contribute to an individual's highest potential quality of life when considering each of the three available AFO design options, and 2. Develop prediction models of clinical performance using biomechanical function linked to the three AFO designs. Participants will be asked to: * Wear each of the three modern AFO designs for one month, after receiving therapy training and * Complete questionnaires and performance tests with each AFO. In addition, the subset of individuals participating in goal 2) will also be asked to: * Perform biomechanical analyses using high-speed cameras and force plates during different walking and balance tests with each AFO design.
Interventions
- Device Pre-fabricated (PF) ankle-foot orthosis (AFO)
These pre-manufactured orthoses are customized to fit each patient. These devices can help to distribute weight evenly along the foot, but do not offer much opportunity for adjustment to a patient's specific needs. These AFOs achieve ankle motion through material deflection and lack a single point of articulation. - Device Carbon-strut (CS) ankle-foot orthosis (AFO)
These AFO designs are built from a custom mold of the patient's affected limb for a more individualized fit. It includes a solid ankle design and achieves ankle motion through material deflection and lacks a single point of articulation. - Device Multifunctional articulating (MA) ankle-foot orthosis (AFO)
These AFO designs are also built from a custom mold of the patient's affected limb, but these orthoses have a true articulation at the ankle to provide controlled ankle movement in a range determined appropriate by the orthotist through gait analysis.
Primary outcome measures
- Health-related quality of life (HRQoL) [Time frame: Over the real-world use period (4 weeks) for each AFO]
Eligibility criteria
Inclusion criteria
- be a minimum of three months post-stroke
- be greater than 18 years of age
- have been prescribed either a semi-rigid or a custom-made articulating AFO
- wear their prescribed AFO for all primary mobility activity outside the house
- be able to walk at least 20 meters without manual assistance
- walk at least 10 meters per minute (12% of normal velocity) during a 6-meter self-selected velocity walking test.
Exclusion criteria
- having a condition that could significantly limit ambulation, including severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or pre-existing neurological disorder other than post-stroke
- having cognitive deficits that preclude their ability to provide consent for participation
- having an ankle plantar flexion contracture equal to or greater than 15 degrees plantar flexion with full knee extension
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Rancho Research Institute — Downey
- Brooks Rehabilitation — Jacksonville
- Medical University of South Carolina — Charleston
- Hanger Clinic — Houston
Publications
- Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995 Jan 4;273(1):59-65. PMID 7996652
Identifiers
NCT: NCT06692686 · STUDY00006128 · CDMRP-OP230030